University Hospital
Linköping, Östergötland County, 58183, Sweden
NCT Number: NCT02454400
The aim is to study if pre-surgery physiotherapy improves function, pain and health in patients with specific low back pain scheduled for surgery. Patients are followed over a two year period. A secondary aim is to study what factors predict short and long term outcomes.
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Notify Me25 year–80 year
All sexes
Interventional
Not applicable
Linköping, Östergötland County, 58183, Sweden
The design is a randomized controlled trial, where patients are allocated either to pre-surgery physiotherapy or waiting-list when scheduled for surgery due to specific low back pain (spinal stenosis, disc herniation, spondylolisthesis, disc degenerative disease (DDD)).
The patients are scheduled for surgery due to specific low back pain diagnosis and randomized to either pre-surgery physiotherapy or waiting-list group. Clinical measurement and treatment-classification is done before and after intervention.
Pre-surgery intervention:
Physiotherapy guided intervention twice a week for nine weeks. The program includes:
Both groups receive standardized information about surgery, post-surgery rehabilitation and to stay active.
Surgery in performed according to existing guidelines.
Measurements:
Patients fill out a questionnaire at baseline, before surgery (after pre-surgery physiotherapy or waiting-list), three months, one and two years after surgery. The questionnaire includes self-reported measures for function Oswestry Disability Index (ODI) (primary outcome), pain (VAS, pain drawing, pain duration) and health (SF-36, EQ-5D), anxiety, depression (HADS), self efficacy, fear avoidance belief questionnaire (FABQ), workability, (WAI), expectations, general information of work, sick-leave, lifestyle behavior, previous healthcare consumption, patient reported treatment effects, patient enablement instrument (PEI), and adverse events.
Clinical measurement is done before and after intervention. Clinical measurements includes; isometric quadriceps strength, walking-test, neurological tests for L4-S1, SI-joint tests, Posterior-anterior-test (PA-test), test for centralization, test for aberrant movements.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients that are scheduled for surgery due to following diagnoses;
Exclusion criteria
Physiotherapy guided intervention twice a week for nine weeks. The program includes:
Standardized information about:
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Self reported pain in lumbar and leg pain respectively
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Self reported pain in lumbar and leg pain respectively
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Self reported health
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Self reported anxiety and depression
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Self reported self efficacy
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Self reported fear avoidance belief questionnaire
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Self reported workability
Linkoeping University
Other Gov
Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT
Acronym: PREPARE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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